FDA.reportPublic FDA data

Vivid

Primary DI
00840682147064
Brand
Vivid
Company
GE Vingmed Ultrasound A/S
Model
E v203 to v204 UPG
Published
2020-08-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ITXTransducer, ultrasonic, diagnostic
IYNSystem, imaging, pulsed doppler, ultrasonic
IYOSystem, imaging, pulsed echo, ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2
IYNSystem, Imaging, Pulsed Doppler, UltrasonicRadiology2
IYOSystem, Imaging, Pulsed Echo, UltrasonicRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200743000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200743000Vivid E80/ Vivid E90/ Vivid E95Ge Medical Systems Ultrasound And2020-07-23IYN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840682147064PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840682147064008406821470648406821470640840682147064

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(999)999-9999xx@xx.xx

Regulatory Flags#

DUNS number
518870571
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840682115759NAP6D-RSKQ1000072016-07-15
00198953200421EchoPACSoftware Only v2112026-10-07
00198953200438EchoPACPlug-In v2112026-10-07
00195278951700EchoPACSoftware Only v2102025-08-08
00195278951717EchoPACPlug-In v2102025-08-08
00198953126073VividFocusTC0010112026-09-21
00198953172384VividExplorer2026-09-21
00198953172551VividAdvancedTC0010122026-09-21
00195278875860VscanAir CL2025-07-04
00195278504302EchoPACSoftware Only v2062022-08-23
00195278504326EchoPACPlug-in v2062022-08-23
00195278388483NA9VT-DKN1001302022-07-29
00195278435743VividE v204 4D ICE UPG2021-06-24
00198953157145Vscan AirR3.2 for Android2026-05-11
00198953157152Vscan AirR3.2 for iOS2026-05-11
00840682146647VividE80 v204 with OLED2020-08-12
00840682146661VividE80 v204 with LCD2020-08-12
00840682146678VividE90 v204 with OLED2020-08-12
00840682146692VividE90 v204 with LCD2020-08-12
00198953079249VscanAir R3.1 for Android2025-11-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719873001101Esaote MyLabX1 Diagnostic Ultrasound SystemQISDA CORPORATIONIYO2026-11-04
04719873001101Esaote MyLabX1 Diagnostic Ultrasound SystemQISDA CORPORATIONIYN2026-11-04
04719873001101Esaote MyLabX1 Diagnostic Ultrasound SystemQISDA CORPORATIONITX2026-11-04
04719873001132Esaote MyLabX1 Diagnostic Ultrasound SystemQISDA CORPORATIONIYN2026-11-04
04719873001132Esaote MyLabX1 Diagnostic Ultrasound SystemQISDA CORPORATIONITX2026-11-04
04719873001132Esaote MyLabX1 Diagnostic Ultrasound SystemQISDA CORPORATIONIYO2026-11-04
04719873001156Esaote MyLabX1 Diagnostic Ultrasound SystemQISDA CORPORATIONIYO2026-11-04
04719873001156Esaote MyLabX1 Diagnostic Ultrasound SystemQISDA CORPORATIONIYN2026-11-04
04719873001156Esaote MyLabX1 Diagnostic Ultrasound SystemQISDA CORPORATIONITX2026-11-04
06903053063852Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-10-31
06903053063869Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-10-31
06903053063876Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-10-31
06903053063883Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-10-31
06903053063890Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYO2026-10-31
06903053063890Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-10-31
06903053063890Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.ITX2026-10-31
06903053063906Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-10-31
06903053063913Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-10-31
06903053063937Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-10-31
06903053063944Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-10-31
06903053063944Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYO2026-10-31
06903053063944Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.ITX2026-10-31
06903053063951Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-10-31
06903053063968Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-10-31
06903053063975Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-10-31
06903053063982Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-10-31
06903053064002Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.ITX2026-10-31
06903053064002Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYO2026-10-31
06903053064002Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-10-31
06903053064019Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-10-31